Safety

Geodon (ziprasidone HCl) Capsules and Oral Suspension and Geodon (ziprasidone mesylate) Injection

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)

August 2015

Summary View

WARNINGS AND PRECAUTIONS

Severe Cutaneous Adverse Reactions
  • Other severe cutaneous adverse reactions, such as Stevens-Johnson syndrome, have been reported with ziprasidone exposure. Severe cutaneous adverse reactions are sometimes fatal. Discontinue ziprasidone if severe cutaneous adverse reactions are suspected

 

July 2013

Summary View

WARNINGS AND PRECAUTIONS

Metabolic Changes
  • Atypical antipsychotic drugs have been associated with metabolic changes that may increase cardiovascular/cerebrovascular risk. These metabolic changes include hyperglycemia, dyslipidemia, and body weight gain. While all of the drugs in the class have been shown to produce some metabolic changes, each drug has its own specific risk profile.
     

 

March 2013

Summary View

WARNINGS AND PRECAUTIONS

Hyperprolactinemia
  • ...Long-standing hyperprolactinemia when associated with hypogonadism may lead to decreased bone density.

 

Page Last Updated: 09/10/2015
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